SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method)
Manufactured by Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd., China - ndh-biotech.com
Device identification number
1755
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
85.71 % IgM (5/105)
False positives
92.13 % IgG (10/127)
False negatives
95.49 % IgG (6/133)
False negatives
98.67 % IgM (6/125)
Precision
Evaluated
Accuracy
93.85 % (IgG)
Accuracy
90.87 % (IgM)
Reproducibility
Evaluated
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
92.13 % (IgG)
Clinical Sensitivity
85.71 % (IgM)
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements